Overview
Glyburide is a second generation sulfonylurea used to treat patients with diabetes mellitus type II. It is typically given to patients who cannot be managed with the standard first line therapy, metformin. Glyburide stimulates insulin secretion through the closure of ATP-sensitive potassium channels on beta cells, raising intracellular potassium and calcium ion concentrations. Glyburide was granted FDA approval on 1 May 1984. A formulation with metformin was granted FDA approval on on 31 July 2000.
Background
Glyburide is a second generation sulfonylurea used to treat patients with diabetes mellitus type II. It is typically given to patients who cannot be managed with the standard first line therapy, metformin. Glyburide stimulates insulin secretion through the closure of ATP-sensitive potassium channels on beta cells, raising intracellular potassium and calcium ion concentrations. Glyburide was granted FDA approval on 1 May 1984. A formulation with metformin was granted FDA approval on on 31 July 2000.
Indication
Glyburide is indicated alone or as part of combination product with metformin, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
Associated Conditions
- Gestational Diabetes Mellitus (GDM)
- Glycemic Control
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/10 | Not Applicable | Not yet recruiting | |||
2023/01/18 | Phase 2 | Recruiting | |||
2023/01/18 | Phase 3 | Not yet recruiting | |||
2022/06/22 | Phase 1 | Recruiting | |||
2021/12/08 | Phase 1 | UNKNOWN | Beijing Tiantan Hospital | ||
2021/11/30 | Phase 4 | UNKNOWN | Beijing Tiantan Hospital | ||
2021/07/14 | Not Applicable | Completed | |||
2021/04/26 | Phase 1 | Completed | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2020/01/18 | Not Applicable | Completed | |||
2019/05/17 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 68071-2402 | ORAL | 5 mg in 1 1 | 5/13/2021 | |
| Aurobindo Pharma Limited | 65862-082 | ORAL | 5 mg in 1 1 | 3/16/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-5215 | ORAL | 5 mg in 1 1 | 4/5/2021 | |
| Blenheim Pharmacal, Inc. | 10544-580 | ORAL | 2.5 mg in 1 1 | 2/18/2015 | |
| NuCare Pharmaceuticals,Inc. | 68071-5029 | ORAL | 2.5 mg in 1 1 | 2/19/2021 | |
| Aidarex Pharmaceuticals LLC | 33261-209 | ORAL | 5 mg in 1 1 | 1/4/2014 | |
| Teva Pharmaceuticals USA, Inc. | 0093-8036 | ORAL | 6 mg in 1 1 | 9/12/2023 | |
| Bryant Ranch Prepack | 71335-0069 | ORAL | 2.5 mg in 1 1 | 4/2/2021 | |
| Pharmacia & Upjohn Company LLC | 0009-0352 | ORAL | 3 mg in 1 1 | 12/6/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2589 | ORAL | 5 mg in 1 1 | 4/25/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/24/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CLAMIDE TABLET 5 mg | SIN07380P | TABLET | 5.00MG | 4/3/1993 | |
| GLYBORAL TABLET 5 mg | SIN11789P | TABLET | 5 mg | 1/26/2002 | |
| T.O.NIL TABLET 5 mg | SIN10998P | TABLET | 5 mg | 6/26/1999 | |
| APO-GLYBURIDE TABLET 5 mg | SIN04842P | TABLET | 5 mg | 6/26/1990 | |
| BENIL TABLET 5 mg | SIN07284P | TABLET | 5 mg | 12/3/1992 | |
| GLIMIDE TABLET 5 mg | SIN04206P | TABLET | 5 mg | 4/17/1990 | |
| GLUCOVANCE TABLET 500 mg/5 mg | SIN12322P | TABLET, FILM COATED | 5 mg | 6/23/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Glibenclamide Capsules | 国药准字H20010068 | 化学药品 | 胶囊剂 | 5/9/2020 | |
| Glibenclamide Tablets | 国药准字H21021719 | 化学药品 | 片剂 | 8/26/2020 | |
| Glibenclamide Tablets | 国药准字H20068140 | 化学药品 | 片剂 | 7/9/2021 | |
| Glibenclamide Tablets | 国药准字H23020093 | 化学药品 | 片剂(素片) | 7/27/2020 | |
| Glibenclamide Tablets | 国药准字H23022317 | 化学药品 | 片剂(素片) | 6/29/2020 | |
| Glibenclamide Tablets | 国药准字H13022337 | 化学药品 | 片剂 | 10/27/2020 | |
| Glibenclamide Tablets | 国药准字H61022920 | 化学药品 | 片剂 | 2/9/2021 | |
| Glibenclamide Tablets | 国药准字H13020033 | 化学药品 | 片剂 | 9/2/2020 | |
| Glibenclamide Tablets | 国药准字H13022852 | 化学药品 | 片剂 | 10/16/2020 | |
| Glibenclamide Tablets | 国药准字H44023709 | 化学药品 | 片剂 | 1/7/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GLUCOVANCE 500/5 metformin hydrochloride 500 mg and glibenclamide 5 mg tablet blister pack | 96729 | Medicine | A | 8/5/2004 | |
| DAONIL 5mg Tablets | 73683 | Medicine | A | 4/27/2000 | |
| GLUCOVANCE 250/1.25 metformin hydrochloride 250 mg and glibenclamide 1.25 mg tablet blister pack | 96725 | Medicine | A | 8/5/2004 | |
| GLUCOVANCE 500/2.5 metformin hydrochloride 500 mg and glibenclamide 2.5 mg tablet blister pack | 96728 | Medicine | A | 8/5/2004 |